EMA under fire for blocking data access
pharmafile | June 8, 2010 | News story | Research and Development, Sales and Marketing | Acomplia, Alli, EMA, Xenical, data
The European ombudsman has called for the European Medicines Agency to grant access to clinical study reports and trial protocols for three anti-obesity drugs.
These are orlistat (the key ingredient in both Roche’s prescription drug Xenical and GlaxoSmithKline’s OTC brand Alli) and rimonabant (Sanofi-Aventis’ controversial Acomplia).
The ombudsman, P. Nikiforos Diamandouros, ruled that: “EMA should grant the complainants access to the requested documents or provide a convincing explanation as to why no such access can be given.”
He went so far as to say that the EMA’s refusal amounted to an example of maladministration.
The case dates back to 2007, when Danish researchers were refused access because EMA said disclosure would undermine the manufacturers’ commercial interests.
Xenical has been available for more than a decade, while GSK’s lower-dose version of the weight-loss pill is a newer entrant to the market and available in the US and Europe under the brand name Alli.
Meanwhile, Acomplia was withdrawn a few years ago when doctors became concerned about increased levels of depression and suicidal thinking seen in patients.
The complainants against the EMA – researchers at the Denmark-based Nordic Cochrane Centre – wanted to conduct their own analysis because they said trial data was sometimes biased.
But EMA invoked article 3(2)(a) in the rules for the implementation of Regulation (EC) No 1049/2001 on access to EMA documents, which refers to “commercial interests of a natural or legal person, including intellectual property”.
The complainants asked the EMA to explain why it thought pharma’s commercial interests should override the welfare of patients.
The EMA said it was not its policy to make available original data which had been submitted as part of an application for marketing authorisation.
The researchers had also argued that the study reports and protocols requested would not undermine any commercial interest.
Crucially, Diamandouros agreed with this last point and the EMA now has until the end of August to respond to the ombudsman’s judgment.
Adam Hill
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